FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraMIST Treatment Wand
DI: 00816789010204
·
Model: CP-80033
·
ALLIQUA BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UltraMIST Treatment Wand
- Primary DI
- 00816789010204
- Version / Model
- CP-80033
- Catalog Number
- CP-80033
- Company Name
- ALLIQUA BIOMEDICAL, INC.
- Labeler DUNS
- 872967679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7a4eada4-22bd-439f-86af-27a32c118613
Device Description
A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electrical energy into low frequency ultrasound energy for application to a wound site via a fluid mist to promote wound healing. It is a non-contact device which may include a display / controls, intended to connect proximally to the system generator and distally to a disposable applicator. It is used in conjunction with a fluid source such as saline with the ultrasound-conductive mist directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRB | Wound Cleaner, Ultrasound | General, Plastic Surgery | 878.4410 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62140 | Wound therapy ultrasound system handpiece | A hand-held mains electricity (DC-powered) electronic component of a wound therapy ultrasound (US) system intended to convert (transduce) electrical energy into low frequency US energy for application to a wound site, via a fluid mist, to promote wound healing. It is a non-patient-contact device, which may include a display/controls, intended to connect proximally to the system generator and distally to a handpiece tip. It is used in conjunction with a fluid source (e.g., saline), whereby an ultrasound-conductive mist is directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816789010201 | GS1 | Corrugated carton | 1 | In Commercial Distribution | |
| Primary | 00816789010204 | GS1 |
Customer Contacts
- Phone
- 844-963-2273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140782 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius